Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Cancer, Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | July 2015 |
An Open-label Trial to Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials
This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA,
EMD Serono or Merck Serono Japan sponsored trial with Tecemotide (L-BLP25) can be enrolled
in this follow-up trial to continue their maintenance treatment with Tecemotide (L-BLP25).
Subjects will be transferred once all feeder trial objectives have been met. Subjects who
received Tecemotide (L-BLP25) in a feeder trial will continue Tecemotide (L-BLP25) treatment
in this follow-up trial and have safety assessments performed as well as be observed for
progressive disease and survival in 6- month intervals. Subjects who had not received
Tecemotide (L-BLP25) in feeder trials, or discontinued treatment will only be observed for
progressive disease and survival in 6-month intervals and will not be provided treatment
with Tecemotide (L-BLP25).
EMD Serono or Merck Serono Japan sponsored trial with Tecemotide (L-BLP25) can be enrolled
in this follow-up trial to continue their maintenance treatment with Tecemotide (L-BLP25).
Subjects will be transferred once all feeder trial objectives have been met. Subjects who
received Tecemotide (L-BLP25) in a feeder trial will continue Tecemotide (L-BLP25) treatment
in this follow-up trial and have safety assessments performed as well as be observed for
progressive disease and survival in 6- month intervals. Subjects who had not received
Tecemotide (L-BLP25) in feeder trials, or discontinued treatment will only be observed for
progressive disease and survival in 6-month intervals and will not be provided treatment
with Tecemotide (L-BLP25).
Inclusion Criteria:
- Signed written informed consent.
- Registration and treatment in a clinical trial with Tecemotide (L BLP25) under
sponsorship of Merck KGaA / EMD Serono / Merck Serono Japan (feeder trial). [Note,
subjects who have been allocated to treatments not containing Tecemotide (L BLP25) in
the feeder trial are eligible for this trial and will be followed-up for PD (if
applicable) and survival.]
- End of Treatment procedures have been performed in the feeder trial.
Additional inclusion criteria also apply.
Exclusion Criteria
- Pregnancy and lactation period; women of childbearing potential, unless using
effective contraception as determined by the Investigator. Subjects whom the
Investigator considers may be at risk of pregnancy will have a pregnancy test
performed per institutional standard.
- Known hypersensitivity to any of the trial treatment ingredients (if applicable).
- Legal incapacity or limited legal capacity.
- Any other reason that, in the opinion of the Investigator, precludes the subject from
participating in the trial.
Additional exclusion criteria also apply.
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